Tolerance & Responsiveness Improvement for Metformin (TRIM)

NCT03670043 | Completed Phase 4 FDA Drug

• 1 other identifier: 1005965
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).

Conditions

Type2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Birmingham Irritable Bowel Syndrome (IBS) Symptom Questionnaire

  This scale is based on symptoms that frequently occur in IBS cases, examines abdominal discomfort status, stool properties, and defecation feelings. The scale includes a total of 11 items, with 6 possible grades for each item that range from 0 points (never having this symptom) to 5 points (the symptom is always present). The total score is the sum of the scores for each item. The Total score is used. No "subscale" is used. Total range is minimum=0, maximum=55. The higher values represent a worse outcome.

  3 months

Study Arms (2)

Metformin ER

ACTIVE COMPARATOR

The subjects developing GI-related symptoms with metformin will be randomized to Metformin Extended Release (ER)

Drug: Metformin Extended Release Oral Tablet

Psyllium

EXPERIMENTAL

The subjects developing GI-related symptoms with metformin will be randomized to Psyllium

Drug: Psyllium powder

Interventions

Psyllium powder DRUG

To evaluate whether Psyllium will alleviate diarrhea

Psyllium

Metformin Extended Release Oral Tablet DRUG

Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin

Metformin ER

Eligibility Criteria

• Age: 20 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male (M)
• African American (AA) race
• Age 20-70 years
• BMI 28-59 kg/m2
• T2D
• A1c 6.5 - 8.9%
• eGFR =/\> 30
• Drug-naïve or use Glipizide or newly started on Metformin (within 2 weeks).

You may not qualify if:

• Chronic kidney disease stage 3b, 4 and 5 (eGFR \< 30)
• Insulin use
• Oral steroids use (inhalers and creams are allowed)
• Antibiotic use within the last month
• Artificial heart valves
• Hospitalization for chronic condition within 6 months prior to the study
• History, manifestations or medications of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, psychiatric/ psychological disorders, or social circumstances which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject.
• Use of other antidiabetic drugs (except glipizide and metformin).
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
• Previous severe allergic reaction to metformin hydrochloride, such as angioedema.
• Previous Metformin intolerance causing significant diarrhea or GI-upset. Would not exclude participants who had history of mild diarrhea with metformin use.
• Previous side effects that the subject feels were related to Metformin and the subject is not interested to re-try metformin.

Sponsors & Collaborators

• West Side Institute for Science and Education: lead

Study Sites (1)

Jesse Brown VA Medical Center

Chicago, Illinois, 60612, United States

Location

Study Officials

• Barengolts

  Jesse Brown VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Endocrinology

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: March 19, 2019
• Primary Completion: October 15, 2020
• Study Completion: August 15, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)